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Second Sight Announces First Commercial Implants of the Argus® II Retinal Prosthesis System In the United States

Argus® II is the first approved bionic eye in the U.S. for the treatment of blindness due to Retinitis Pigmentosa

Sylmar, CA, January 29, 2014 - Second Sight Medical Products Inc. (Second Sight) today announced that the Argus II Retinal Prosthesis System was implanted in patients with Retinitis Pigmentosa (RP) in the U.S. since it was approved by the U.S. Food and Drug Administration (FDA) last year.

This follows the first ever commercial implant of Argus II which took place in Italy in 2011. There have been 18 reimbursed procedures in Germany and 12 in Italy since then. It is hoped that the U.K. will reimburse the treatment next. The NHS’s Prescribed Specialized Services Advisory Group (PSSAG) is considering whether to include Argus II in a list of treatments that are intended for fewer than 500 cases per year in England within the definition of specialized services.

These first U.S. commercial implants were performed at the University of Michigan’s Kellogg Eye Center by K. Thiran Jayasundera, MD, FRCSC, and David N. Zacks, MD, PhD. Dr. Stanislao Rizzo, Director of the University Hospital Ophthalmic Department in Pisa, Italy, who first implanted the Argus II in Europe, provided guidance throughout the first procedure. Dr. Rizzo has performed the largest number of implants on patients worldwide since receiving CE Mark in 2011. Ultimate outcomes will not be known for some period of time until the patients go through a period of rehab to train them on using the Argus II.

Kellogg Eye Center has been selected by Second Sight as a "Centre of Excellence" for its cutting-edge approach to medicine and unparalleled commitment to patient care. It is one of 12 centres in the U.S. that are currently accepting consultations for patients.

"This is a tremendous milestone, not only for Kellogg Eye Center and Second Sight, but also for those affected by RP in the United States," stated Robert Greenberg, MD, PhD, President and CEO of Second Sight. "We are pleased to have the first implants take place at such a nationally recognised and respected institution. This device is going to positively impact the lives of those suffering from RP by providing renewed visual capabilities, which can help improve daily functioning and activities."

In February 2013, after more than 20 years of research and development, Argus II received FDA approval making it the first and only approved long-term therapy for people with advanced RP in the U.S. In August 2013, the Centers for Medicare & Medicaid Services (CMS) authorized both a new technology add-on payment (inpatient setting of care) and a transitional pass-through payment (outpatient setting of care) for the Argus II. These temporary payments are intended to facilitate access to new technologies for Medicare beneficiaries.

"Until now, we've had no treatment options to offer our patients with advanced RP," said Kellogg's Thiran Jayasundera, MD. "We hope the implant will bring light back into our patients' worlds, allowing them to detect shapes of people and objects in their environment. It could allow them to gain more independence and the ability to go about their daily lives with more confidence."

The Kellogg Eye Center has already selected other patients to receive the Argus II in the coming weeks, while several other centers of excellence are also preparing for their first implants. Second Sight is actively partnering with additional hospitals throughout the U.S. to make the therapy more readily available.

About Retinitis Pigmentosa (RP) RP is a rare, hereditary disease that causes a progressive degeneration of the light-sensitive cells of the retina, leading to significant visual impairment and ultimately blindness. There are an estimated 1.2 million people worldwide with RP. Second Sight's Argus II System employs electrical stimulation to bypass the defunct cells and stimulate remaining viable retinal cells inducing visual perception in blind individuals. The Argus II is the first artificial retina to receive approval in Europe (CE Mark) and in the USA.

About the Argus® II System The Argus II System works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function. Argus II is the first and the only retinal prosthesis approved in the U.S.

About Second Sight Second Sight Medical Products, Inc., located in Los Angeles, California, was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations such as RP. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. U.S. Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland.